The following data is part of a premarket notification filed by Great Lakes Orthodontics, Ltd. with the FDA for Great Lakes Paste Solder.
| Device ID | K832425 |
| 510k Number | K832425 |
| Device Name: | GREAT LAKES PASTE SOLDER |
| Classification | Alloy, Other Noble Metal |
| Applicant | GREAT LAKES ORTHODONTICS, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJS |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-22 |
| Decision Date | 1983-10-04 |